AVA6103 in Subjects With Locally Advanced or Metastatic Selected Solid Tumors
Trial Parameters
Brief Summary
This is a first-in-human (FIH), Phase 1 open-label, multicenter dose escalation study investigating AVA6103 monotherapy administered intravenously in patients with locally advanced (unresectable) or metastatic solid tumors that are likely to be FAP positive. The study consists of an initial Phase 1a dose escalation portion and a subsequent Phase 1b dose expansion portion upon completion of the dose escalation portion.
Eligibility Criteria
Inclusion Criteria: 1. The subject is fully informed about the study and is willing and able to sign the informed consent form (ICF). 2. Male or female subjects, ≥18 years of age. 3. Subjects with the following tumors reported to be FAP positive, with histological or cytological confirmation of a locally advanced (unresectable) and/or metastatic progressing disease that have received all standard-of-care or Food and Drug Administration (FDA) approved treatments, or are ineligible for those treatments, or decline those treatments 1. Cervical/vulvar cancer 2. SCLC 3. Gastric/GEJ cancer 4. PDAC 4. Has a life expectancy of ≥3 months, in the opinion of the investigator. 5. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. Has recovered from all acute toxic effects of any prior radiotherapy, chemotherapy, or surgical procedure (must have resolved to CTCAE Grade ≤1 or returned to baseline, whichever is greater. Exceptions include alopecia and peripheral neuropa